Trials / Completed

CompletedNCT02462850

A Multi-Center Actual-Use Study on the Safety of CL 108 for the Treatment of Moderate to Severe Acute Pain Associated With Osteoarthritis of the Knee or Hip

A Phase 3 Multi-Center Actual-Use Study on the Safety of CL 108 for the Treatment of Moderate to Severe Acute Pain Associated With Osteoarthritis of the Knee or Hip

Status: Completed
Phase: Phase 3
Study type: Interventional
Enrollment: 178 (actual)

Sponsor: Charleston Laboratories, Inc · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

Detailed description

The purpose of CLCT-006, a multi-center open-label study, is to evaluate the safety of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) for the treatment of moderate to severe acute pain ("flare") associated with osteoarthritis of the knee or hip under actual conditions of use. The study will also endeavor to determine * the physicians' global evaluation of CL-108 as a treatment for moderate to severe acute pain associated with osteoarthritis of the knee or hip * the patients' global impression of change in pain after treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip * any change in the patient's quality of life after treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip * the percentage change in pain intensity after treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip

Conditions

Interventions

Type	Name	Description
DRUG	CL-108

Timeline

Start date: 2014-10-01
Primary completion: 2015-01-01
Completion: 2015-02-01
First posted: 2015-06-04
Last updated: 2016-11-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02462850. Inclusion in this directory is not an endorsement.